BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS

    MDR report key: 9118782 · Received September 25, 2019

    Report

    Report Number
    8030965-2019-68678
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    August 27, 2019
    Report Date
    August 27, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWB
    UDI-DI
    07611819056527
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1), UNKNOWN HOLLOW REAMER (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1); UNKNOWN SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 309.069. LOT: 7980646. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 08.AUG.2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL SURGERY FOR TOMOFIX PLATE DUE TO BONE UNION. THE IMPLANT HAD BEEN IN PATIENT BODY FOR ABOUT 3 YEARS. DURING SCREW REMOVAL, THE SCREW BROKE AT ITS NECK. THE SURGEON USED THE EXTRACTION BOLT AFTER REAMING WITH HOLLOW REAMER. HOWEVER, THE BOLT DID NOT HOLD THE BROKEN SCREW AND HE COULD NOT REMOVE IT. TWO (2) BROKEN SCREWS WERE LEFT IN THE PATIENT'S BODY. THE SECOND AND THIRD SCREWS FROM THE DISTAL SIDE OF THE PLATE WERE BROKEN. THE SURGERY WAS DELAYED BY LESS THAN THIRTY (30) MINUTES. THERE IS NO PLAN TO PERFORM RE-OPERATION CURRENTLY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1), UNKNOWN HOLLOW REAMER (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1). THIS REPORT IS FOR ONE (1). EXTRACTION BOLT FOR 6.5 MM & 7.0 MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911961 EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS EXTRACTOR HWB OBERDORF SYNTHES PRODUKTIONS GMBH 7980646 07611819056527

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - PLATES: TOMOFIX OSTEOTOMY| UNK - PLATES: TOMOFIX OSTEOTOMY| UNK - REAMERS| UNK - REAMERS| UNK - SCREWS: TRAUMA| UNK - PLATES: TOMOFIX OSTEOTOMY| UNK - REAMERS